Earnings Call Transcript - VNRX Q1 2024

Operator, Operator

Good morning, ladies and gentlemen, and thank you for standing by. Welcome to VolitionRx Limited First Quarter 2024 Earnings Conference Call. This conference call is being recorded today, May 14, 2024. I would now like to turn the conference over to Louise Batchelor, Group Chief Marketing and Communications Officer. Please go ahead.

Louise Batchelor, Group Chief Marketing and Communications Officer

Thank you, and welcome, everyone, to today's earnings conference call for VolitionRx Limited. Before we begin, I'd like to remind everyone that some of the information discussed on this conference call will include forward-looking statements covered under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are based on our beliefs as well as assumptions we have used based upon information currently available to us. Because these statements reflect our current views concerning future events, these statements may involve risks, uncertainties and assumptions. Actual future results may vary significantly based on a number of factors that may cause the actual results or events to be materially different from future results, performance or achievements expressed or implied by these statements. We have identified various risk factors associated with our operations in our most recent annual report on Form 10-K, quarterly reports on Form 10-Q and other filings with the Securities and Exchange Commission. We do not undertake any obligation to update any forward-looking statements made during the course of this call. We will start the call today with Terig Hughes, our Group Chief Financial Officer, who will cover Volition's financial and operating results for the third quarter of 2024, along with a discussion of recent finance activities and the look ahead. Dr. Andrew Retter, our recently appointed Chief Medical Officer, will provide a commentary about our clinical trial program, and then Gael Forterre, our Chief Commercial Officer, will summarize some of the key commercial achievements this quarter with a look ahead to upcoming milestones. Lastly, Cameron Reynolds, our President and Group Chief Executive Officer, will provide a brief wrap-up before we open the conference call to a question-and-answer session. I'll now turn the call over to Terig.

Terig Hughes, Group Chief Financial Officer

Thanks, Lou, and thank you, everyone, for joining Volition's First Quarter 2024 Earnings Call today. We do appreciate your time given the busy earnings season. I'll now provide a summary of the key financial results for the quarter ending March 31, 2024. We ended the quarter with cash and cash equivalents of approximately $11.8 million. Throughout this quarter, we have continued to work on a number of threats with the aim of ensuring Volition is cash flow neutral in 2025. We are making strong and necessary decisions to preserve capital in the company whilst ensuring we deliver on our vision and mission. Firstly, from a funding perspective, as you are probably aware, throughout the company's history, we have been successful in securing non-dilutive funding on favorable terms, and year-to-date, we have targeted a range of government agencies, including in the U.S., to fund or co-fund some of our strategic projects up to $25 million. In addition, we have applied for or are in the process of applying for an additional $18 million from various European agencies. As a reminder, we have previously received over $20 million in non-dilutive funding support from various Belgian and European agencies. We will provide further updates on this in the coming months. Secondly, as Andy and Gael will cover later, we are working hard to complete the materials for our data rooms during the second quarter for Nu.Q NETs and Capture-PCR to enable licensing negotiations to move forward. If successful, we believe that this strategy, like the approach we took with Nu.Q Vet, could provide us with ongoing royalties and very meaningful milestone payments in the next 12 months. Thirdly, now that we expect that we are very close to receiving large amounts of data for both Nu.Q NETs and Capture-PCR, subsequent to the quarter end, we took some necessary actions in order to significantly reduce expenditures and cash burn as we focus on commercialization. Our goal is to reduce expenditures by $10 million on an annualized basis. Additionally, to demonstrate their continued commitment and belief in the long-term potential of the company, the Board of Directors intends to take 50% of their fees in equity for a minimum of 6 months, and the leadership team intends to take a percentage of their salaries in equity for a minimum of 6 months, ranging from 10% to 50%, with our group Chief Executive Officer, Cameron Reynolds, taking 50%. We have also postponed the payments of any cash bonuses indefinitely. We have invested significantly over recent years to build out our product pillars and to ensure we have robust scientific and clinical evidence to support our potential breakthrough technologies. Following our anticipated receipt by the end of June of a substantial amount of clinical data, we intend to have a laser focus on commercializing our potentially groundbreaking technologies. From a revenue perspective, this quarter, we recorded revenue of approximately $170,000 for the quarter, approximately 15% higher than the same period last year. About 75% of the revenue was from Nu.Q Vet, and the remainder from Nu.Q Discover. The initial phase of a product launch can take time as adjustments are made to the product workflow, marketing, pricing, etc. While the revenue ramp from Nu.Q Vet has taken longer than anticipated, we expect revenues to accelerate in the second half of 2024 due to two very important recent product launches. We are delighted that two additional large distributors have recently come online with our Nu.Q Vet cancer test. Antech Diagnostics, part of the Mars Pet Care Group, announced the launch of the Nu.Q Vet test not only in the U.S. but also in Europe. It was very heartening to see Antech's press release, which included several excellent vet KOL endorsements in both the U.S. and Europe. You might remember from our last call that the vet team was out in Japan supporting Fujifilm Vet Systems at their launch event at the World Veterinary Cancer Congress. Fuji is also pricing the test to vets at below $40 and will market our test aggressively later during the second quarter after very good initial feedback from vets. So we certainly hope to see revenue accelerate in the second half of the year. To sum up, our aim is to become cash flow neutral in 2025 by increasing revenues, cutting costs to reduce expenditures by $10 million on an annualized basis, getting very meaningful further government non-dilutive funding, and licensing milestone payments from Nu.Q NETs and Capture-PCR. As we have said on previous calls, our commercial strategy is to monetize our intellectual property through licensing. To that end, we are delighted with the progress we have made with Nu.Q Vet and with the progress we are making with Nu.Q NETs, Capture-PCR, and Nu.Q Lung Cancer.

Andrew Retter, Chief Medical Officer

Thank you very much, Terig, and good morning, everybody. Thank you for joining us today. I will start by reiterating my conclusions from our last call just a few weeks ago now. I believe that Volition's technologies will not only help with diagnostics enrichment but also with monitoring of patient disease progression and response to treatment. And most incredibly, we should be able to accomplish these goals with a relatively low cost, easily available routine blood test, which can be used widely around the world. We have certainly made excellent progress towards achieving these missions in the last year. Starting first with Nu.Q NETs and Sepsis. I wanted to highlight a couple of studies which we hope will provide strong clinical utility evidence. We have ongoing analysis of two large-scale retrospective sepsis cohorts in Europe, the German sepsis group and work with our team at UMC Amsterdam. This will encompass over 2,500 patients with longitudinal samples. We hope to characterize cohorts of patients with sepsis, and this should be a really rich and valuable source of insight into the value that Nu.Q NETs offers. These samples have now all been run, and we're working on the complex process of data analysis. We aim to have this completed by the end of next month, but we'll have data ready to show soon afterward. We extended the study in the U.S. to include sicker patients and for patients to be initiated from the emergency department rather than simply ITU. This plan is to close out this study in the coming months. In summary, across all the studies to date, without data covering patients from the emergency room presentation through to intensive care units, we will cover key outcome measures with Nu.Q NETs correlated with the Sepsis-3 diagnostic criteria, disease severity, specifically picking out risk of development of organ failure and types of organ failure, intensive care mortality, 28-day mortality, duration of organ supportive therapies, and length of stay in hospital and in ITU. We believe that this data will significantly strengthen the contents of our confidential data room to support our ongoing commercial discussions by the midpoint of this year. Our project with key opinion leader, Professor Djillali in France, is also progressing well. This is a consortium project of an ongoing prospective study of which Volition is a key member. Again, it's longitudinal in nature and large scale with anticipated recruitment of about 1,500 patients. Finally, the EPICTETUS study at my own hospital, Guy’s & St Thomas in London, is now underway with our first patient recruited in December last year. From a publication perspective, we're making solid progress. Following on from our key opinion leader event last year, I have been working closely with the clinicians on the clinical review article, with our intention to submit it for peer review by the end of June and hopefully publication shortly thereafter. We received positive feedback from our publication by one of our colleagues, Kieran Zukas. We have addressed the reviewer's questions, and the paper has been resubmitted. We hope to hear back confirmation that it will be published very shortly. Findings of the synthetic sepsis model emphasize the importance of investigating neutrophil physiology and biology. This is relevant to enable us to have a better understanding of disease pathology, risk factors, and factors that trigger neutrophils and lead to an excessive immune response. Ultimately, this will lead us to identify therapeutic targets to allow intervention and hopefully change the trajectory and improve outcomes for patients with sepsis. We have a robust scientific pathway strengthening our evidence as we continue to develop and supplement our clinical data to support our scientific rationale. We aim to publish more papers over the coming year. We anticipate a number of the clinical studies that I mentioned earlier will report out at the European Society of Intensive Care meeting, a flagship event in Barcelona in October. We're also proudly sponsoring our first satellite symposium, and the session will be chaired by Professor Djillali Annane at the Congress. We expect all of these activities to help us continue to build momentum and generate licensing interest. One final comment on Nu.Q NETs before I move on to our cancer technologies. I would like to reiterate that the sense from the KOL group was that Nu.Q NETs potentially represent one of the biggest breakthroughs in sepsis management in the last 30 years, potentially helping us to diagnose, monitor, and treat patients more efficiently and hopefully save many lives. We have many more details to follow, but it certainly looks like a very busy and exciting year ahead for Nu.Q NETs and sepsis. Cancer, as we all know, is a very serious and deadly disease, causing almost 10 million deaths in 2020. The incidence of cancer is forecast to increase in our population ages, with an estimate of around 30 million new cases diagnosed each year by 2040. Like many diseases, early diagnosis of cancer has a significant impact on outcomes. Quite simply, the earlier we can diagnose the disease, the greater chance of survival and a better quality of life for our patients. Early diagnosis is, however, very challenging. Often, cancer develops silently with few symptoms and often people are diagnosed only late in the illness when fewer and much more aggressive treatment options are available. Early-stage cancer is difficult to detect because the cancer-derived circulating tumor DNA is low. It may comprise only 0.01% of the DNA present amongst a background of normal cell-free DNA. We’re very excited as Volition has developed a novel method of liquid biopsy involving the first-ever reported physical isolation of a class of tumor-derived ctDNA fragments for blood. These cancer-derived tumor DNA fragments are extracted, and after the removal of the normal background DNA, the cancer DNA is detected and characterized with a low-cost PCR test. We’re calling this new technique Capture-PCR. Volition’s proof of concept data was presented at the European Society of Medical Oncology Conference in 2023. We demonstrated the isolation of tumor-derived DNA fragments from plasma. Volition has tested the new method in a small clinical experiment and detected a range of solid and liquid tumors, including early-stage 1 diseases. These early assays were developed using a leukemia model, but to our surprise, we were also able to detect many other cancers, including colorectal cancer in a blood test with an accuracy approaching that of the current fecal immunochemical tests or FIT tests. Subsequent to our initial poster, Dr. Jake Micallef and team have presented at a number of cancer-specific conferences showing initial data while developing all-important key opinion leader potential centers of excellence network. The team has continued to identify other potential biomarkers and the associated PCR tests, especially in solid cancers to conduct initial clinical studies in larger, more diverse patient cohorts. From a publication perspective, again, we are making solid progress. Jake and the team are working very hard to complete their first manuscript and plan to submit this breakthrough method for peer review by the end of June. This will be an incredibly important paper to add to our data room and support our ongoing commercial discussions. I’m delighted to say ESMO 2024 is just around the corner. Until that end, we have submitted several abstracts for consideration. I’m delighted to say these abstracts are not only Capture-PCR related but also include some significant and very promising new data related to the use of our Nu.Q technology for lung cancer. I will conclude by saying that year-to-date, we have added supporting materials to our data rooms for Nu.Q NET, Capture-PCR, and Nu.Q cancer. Whilst not all of this data is published yet, we are able to share it in commercial discussions under non-disclosure agreements. With that, I’ll hand you over to Gael. Thank you very much for listening, and thank you, Gael.

Gael Forterre, Chief Commercial Officer

Thank you very much, Andy, and good morning, everyone. Before I discuss the data rules and our ongoing commercial discussions, I would like to reflect on our progress so far licensing and commercializing our technology. In relation to the Nu.Q Vet tests, we have received $23 million so far, $10 million upon signing the exclusive agreement for the in-house diagnostic test with Heska, Antech, which is part of the Mars Pet Care Group. We then subsequently received $13 million upon the achievements up to milestones in December 2023. On an ongoing basis, under this agreement, we will also receive payments for the supply of the key component for the Nu.Q Vet cancer test on the Element I+ in-hospital platform. We have also established a number of non-exclusive reference lab supply agreements for this test with global and regional veterinary diagnostic companies, including IDEXX Laboratories and most recently Fujifilm Vet Systems. It is safe to say that we have made significant progress in making our test accessible to veterinarians in a number of major markets in the U.S., Japan, and many European countries. This has been achieved not only through the reference lab network but also by making it available in-hospital at the point of care to give results to the veterinarian in less than 10 minutes. These countries are home to around 150 million pet dogs, so they represent a significant market opportunity. As Tom has mentioned on previous calls, cancer screening in the veterinary market is a new concept, and certainly, while there is significant interest, it is taking time to properly launch, educate, convert, and scale. Through the recent launches by Antech and Fuji, we have seen significant engagement from their teams and the support of several KOLs. Notably, they are both offering the test at a very competitive list price of around $35 to $40 to the veterinarian, which aligns with our desire to keep the test as low cost and therefore as accessible as possible. We look forward to providing a more detailed update regarding this product line on the next call. In the interest of time today, I will simply want to highlight the experience we have accumulated as a business that we might leverage as we move to commercializing some of our other technologies such as, but not limited to, Nu.Q NET and Capture-PCR. As Andy discussed, we have been busy preparing our data rooms to support ongoing discussions and negotiations with interested parties. The nature of these potential licensing and supply agreements is both broad and complex. As you can imagine, there are a range of options we’re discussing from exclusive, non-exclusive, global versus regional, specific clinical indications, or even the components’ part. We have had an incredible amount of interest in our technology so far and are making strong progress on a number of fronts. Key to some of the discussions is the data that Andy alluded to, much of which we expect by the end of the month, as well as some important publications following the semester. The continued development of the key opinion leader network to champion our technology is also very important, and we look forward to hosting our second sepsis KOL workshop in the third quarter and our first Capture-PCR workshop in the coming months. We are on a very positive trajectory as we work to push our technology up the value curve in order to maximize the monetization of our IP through upfront milestone payments and ongoing licensing revenue. In the interest of time, I will pass to Cameron in a moment, but I just wanted to highlight that we also have a number of other programs that are generating commercial interest. With the goal to accelerate our go-to-market strategy, we might consider them early, which may reduce upfront, but also lower the expenses and allow us to accelerate revenues. I look forward to providing further updates later in the year. And with that, I will now pass on to Cameron for a summary. Cameron?

Cameron Reynolds, President and Group Chief Executive Officer

Thanks, Gael, and thanks too to Andy and Terig for their comprehensive reports. In drawing to a close, before I highlight some key points, I would first like to take a moment to acknowledge the tireless dedication, hard work, and encouragement of our retiring Executive Chairman, Dr. Martin Faulkes. Bill has been with us since the company’s very inception 14 years ago. But having recently celebrated his 80th birthday, we’ll now continue to support us as a long-term shareholder and mentor. Thank you, Bill, for your counsel, and thanks also to the outgoing board member, Ed Butcher, for his many years of service. We are active in our search for a new chair and new directors as we seek to further strengthen the commercial acumen of our board. Our focus continues to be on getting each pillar to support itself either through product revenues, milestone payments, our licensing, or other non-dilutive funding in the coming year as well as on the company-wide cost reduction measures of a further $10 million outlined by Terig earlier. This is to ensure as little dilution as possible towards being cash flow neutral as early as possible and then drive towards profitability. We expect Nu.Q Vet revenue to increase in the second half of this year now that Antech and Fuji have launched the products and as existing partners expand into new territories. We’re also focusing on feline product development to secure the final milestone payment of $5 million from Heska Antech. We are also very actively targeting a range of government agencies and currently going through the process to secure further non-dilutive and/or government project funding in the range of $25 million in the U.S. and a further $18 million in Europe. Lastly, as discussed by Gael, there has been a lot of external interest in our Nu.Q Capture-PCR and Nu.Q NET technologies. We have made strong progress through the first half of 2024 in getting the data required, and our strategy is to monetize our IP through licensing agreements. We expect a very large amount of data to be completed by the end of next month in the two key areas of Nu.Q NET and Capture-PCR. If successful, we believe this strategy could provide ongoing royalties and very meaningful milestone payments within the next 12 months. In drawing this earnings call to a close, I would like to thank you all for joining the call today. We very much appreciate it, given how much there is to digest across all our pillars. I’m now happy to answer questions. Operator?

Operator, Operator

Our first question comes from Bruce Jackson of Benchmark Company.

Bruce Jackson, Analyst

The one question I had was about the lung cancer study. Is this the one that’s being done in France in Lyon? And maybe you could give us a few more details about that.

Cameron Reynolds, President and Group Chief Executive Officer

Yes. There’s been a lot happening in Taiwan, primarily related to low dose CT scanning, and the results have been very promising. These findings will soon be published with the intention of incorporating them into the Taiwanese screening program, and we will provide more updates on that later. Additionally, the lung cancer work, which involves our original Nu.Q platform rather than the newer Capture-PCR, is progressing well. It's interesting how everything seems to be coming together at once. After years of having only one or two products, we've seen a mix of decisions regarding palliative care and treatment, which has also yielded positive results. Clinicians are eager to use this approach as well. With all the ongoing work related to sepsis, as Andy mentioned, there has been an incredible level of progress. Despite the focus not being solely on product development, everything appears to be functioning well simultaneously. We plan to emphasize this area more, starting with the publications. Both projects could see clinical use in France later this year or early next year, and in Taiwan once integrated into the national screening program. These are both exciting developments. Does anyone on the team want to add anything about lung cancer? No? I’ve covered it.

Operator, Operator

Our next question comes from Tim Moore of EF Hutton.

Timothy Moore, Analyst

Thanks, and congratulations on the timing of the launches over the last 6 weeks. I mean, like you said, so many things are coming together at once pretty much since late March. That’s really good to see. I know investors have been hanging in there. You’re executing very well. And I was wondering maybe if you don’t mind giving some color and feedback. I know it’s super early, but just what are your thoughts on kind of the feedback and traction at the veterinarians? I know the rollout just pretty much started in the U.S., but vets are probably educating dog owners about it at their annual checkup for the canine test. And just anything you can add on that? Any incidental anecdotes?

Cameron Reynolds, President and Group Chief Executive Officer

Yes. There’s a lot going on there. So I think, obviously, our existing partners, there’s been some time for them to ramp up, but I think that’s understandable. Looking at it so far, there has never been an ecology test in the veterinary space for screening. Certainly not something that’s routine and easy to run like ours. So there’s a vet by vet education process and also how to use the products. There was also, I think, a little bit of market confusion. There was another test on the market from a friend at PetDx, and that’s actually cleared now. They are no longer selling their test. It was something at a very high price point. So, it obviously struggled in the market. It’s no longer around. So I think we have a clear path. One of the very exciting things, with the greater access that we are now developing, through the in-hospital test with Antech and with Fuji in Japan, which only just started, we should see that coming through later in the year, has been the great feedback from key opinion leaders. If you looked at the releases from both companies, some of the best vets in the planet were extremely excited about our product. Going forward, Antech had a large validation study before it put it onto the machine, and it’s got the machine working very, very well. So I think, from the vet perspectives, it’s a building process which is going on in the U.S. And I think the extra access from the two biggest vet companies on the planet and also the biggest in Japan and also through Europe is very encouraging. The feedback we’re getting from the vets, and through those companies, not just our vets but also theirs, has been excellent. We also got great feedback, most recently from Japan from their first use of the product. But this is a development process. There is a lot of work. They are going vet by vet to get them to add it to their normal process. So, it is something which will take some time to get through, but we have a fantastic product. It’s very low cost. The new people in, the new access through Antech and through Fuji are both less than $40 to the vet, so we expect a lot of good developments throughout the end of this year and next year.

Timothy Moore, Analyst

Great, Cameron. And like you mentioned earlier in your remarks, I mean that price point below 40 was definitely very impressive, and I’m glad there’s buying on that, for initial traction and awareness? It seems like a no-brainer for dog owners. The only other quick question I had was on human sepsis. You’re working hard on that. You mentioned the patients and just the studies. Can you just give us a little bit more of a timeframe around that as you look out over the next year, year and a half? Can you kind of just maybe walk us through the timeline and your plan on that because it’s a huge opportunity and everyone thinks, I think, it’s pet testing, but the sepsis could be a huge catalyst. So I’d love to hear more about the timeline?

Cameron Reynolds, President and Group Chief Executive Officer

I think the sepsis is obviously going to be a massive deal because as Andy very well pointed out, this is an absolute potential game changer in the diagnosis and treatment of sepsis. Our test, as we discussed, is always going to be low cost and easy to use on a range of platforms. To get there, this is bigger than Volition. It potentially is such a blockbuster product. We don’t presume that we could launch them internationally ourselves. So we have a very similar model that has worked so well in the vet space to license it out. To license it out, we need a large data, which, Andy went through very well on the call. We’re expecting a lot of that in the next month or two to fill out the data room. We have very strong interest from a range of large companies, and I think the clinching for that is getting large amounts of data. As Andy said, it’s coming up with at least six potential endpoints. How do we correlate with the current sepsis-3 definition, disease severity, intensive care mortality, 28-day mortality, duration of organ support, and length of stay? It’s a huge amount of data. The trials which we’re running have hundreds of data points per patient. They’re very, very large studies with fantastic institutions. Two of the big ones have already run the samples, and we’re analyzing them now as Andy pointed out. So, that’s something which is coming up quite quickly. We’re keen to get the information out for our potential partners to license the product, and we’re also aiming to publish where we can in med archive because sometimes, obviously, large publications can take several months or a few quarters to actually get published. We’re keen where we can to publish that early on med archive. Of course, there’s also our own prospective study, which we’re now calling INCLUDE, which was called the DXOCRO study, and that we should also be reading out in the next two months as well. So a very large amount of data, which with very exciting endpoints, and we’re very encouraged with everything we’ve seen so far. I think there’s a very good chance they’ll become the key points for the data room so we can license them as quickly as possible. The target is to license the sepsis side within the next 12 months and hopefully the cancer PCR this year. So it’s all in the mail now, I think.

Operator, Operator

Our next question comes from Ilya Zubkov of Freedom Broker.

Ilya Zubkov, Analyst

I have a short one on the Capture-PCR. Do you see the Capture-PCR test as a potential product for the biopharma R&D market beyond point of care and hospital screening? Could you elaborate on this?

Cameron Reynolds, President and Group Chief Executive Officer

Yes. I think it’s a big, it’s a whole new technology. The first group ever to concentrate, as Andy said, the chromatin from the cancer. Also, the smaller fragments are incredibly important. And as our chief scientist points out, it’s a whole new array of biomarkers because no one’s ever looked at these fragments and concentrated them before. So there’s a lot of potential uses. The biggest market of all is screening, of course, but there are tremendous amounts of uses in a wide range of areas. If you look at our Nu.Q platform, which is currently what is used in the vet space and the lung cancer trials which we talked about earlier, there’s a lot of work being done in our discovery program. We have over a dozen organizations working with us using our platform, and some of those focus on drug efficacy, and there are a whole lot of, as you said, other ways of using it. I’d certainly expect, once we have the paper and once we’re in the process of licensing, there’s a very wide range of uses they could harness that platform for as we have had on the Nu.Q platform through Nu.Q Discover. I don’t think it’s possible to overstate how important what we’ve done is in the human space and the animal space. We’ve got the only platform, which as I said, does all the things we’ve indicated. So it should have a very important role in a very wide range of other uses beyond screening.

Operator, Operator

Our next question comes from Steven Ralston of Zacks.

Steven Ralston, Analyst

I wonder if you could give some thought to the rollout of Nu.Q Vet, especially here in the United States, Europe, and Japan, it’s imminent or ongoing right now. It seems like a certain percentage of the test will come back positive, and those obvious will, those canines will require treatment. And that brings you into the monitoring aspect. Now I know there was a paper from Dr. Bose and Robles about monitoring about a year ago. What is the procedure? Would the vets have to use that off-label to monitor? It seems like those tests would be rather sticky and that they would be regular over what's very relative short timeframes in order to monitor the progress of the treatment. Could you comment on that?

Cameron Reynolds, President and Group Chief Executive Officer

Yes. Absolutely. I’ll comment firstly then ask Gael to comment on where we are on the monitoring side. But yes. So it would be the same test, and whether it’s off-label or on-label depends on obviously if there’s a publication showing it. It would be something which you’d probably do at least once or twice every month or two when the animal is in relapse. So it’s something which could account for 10 or 20 tests per animal instead of just the one for screening. So, it’s something which is a huge potential market. If there are six million dogs in the U.S. that get cancer every year, if you do 5 or 10 tests per dog on the monitoring side, that’s a huge total addressable market and something which obviously would be a huge market. Someone else on the call comment want to comment exactly where we are with the monitoring?

Gael Forterre, Chief Commercial Officer

Yes, I’m happy, Cameron, to add a little bit of color. Yes, we are working on the monitoring claim, if you will. What we wanted to avoid is as we’re launching screening to add another indication at the same time. So our key focus has been on screening initially, and we started discussion with our partners now to add the additional use. It won’t be, as you mentioned, off-label. It will be something that we back. We just want to make sure as we’re indicating the market we don’t create confusion. So we’re sticking to screening for now, and next later this year, and early next, we’ll launch the monitoring.

Steven Ralston, Analyst

If we could just switch over to sepsis, it seems like you have a slew of papers coming forward with all this data coming through, but it seems like the tip of the spear of this expected series of sepsis studies is Dr. Retter’s clinical study that he did mention has been submitted. Could you get a little more granular about that? Because that seems like it will be the first paper data point that we’ll hear about?

Cameron Reynolds, President and Group Chief Executive Officer

Andy, would you like to go over which data points are most likely in terms of timing?

Andrew Retter, Chief Medical Officer

I can answer that. I think the two retrospective studies will publish first. I’ve seen data already from both of those. We will write them up and submit them for publication, and hopefully, they’ll be published by the end of this year, by end of Q4. The study at St. Thomas’ will finish recruiting in May, June 2025, so I wouldn’t expect that we won’t publish data from that for a little while afterward. But we have five studies ongoing at the moment, and two or three should report out before then. I hope that answers your question. We do have data that we are allowed to share in our confidential data room as well, understanding the data analysis and the analysis, we understand the data better and can provide a richer picture of the results.

Cameron Reynolds, President and Group Chief Executive Officer

And, Steven, I think it’s probably important to say just at this point as well. We obviously have invested a lot over the last six months, eight months to get a lot of data. Andy’s gone through the trials, and they’ll be ready in the data room starting from next month, hopefully, with some very large ones, which have already been run and the prospective ones coming early next year, but a huge amount of data coming very soon. And that was something very important to us. We wanted to ensure we had the very large amount of data that we think is needed to get a good licensee interested in licensing in one of the big diagnosing companies to really launch as quickly as possible. We’ve backed ourselves to get that done, and we’re very close to getting that done now. I think the team I’d like to congratulate everyone in the Volition team that worked tremendously hard over the past few quarters to get all the Capture-PCR data ready, get all the sepsis data ready, work with the teams in Taiwan and Lyon on getting all the lung data ready. There’s a huge avalanche of it coming now starting in the next few weeks, and it will go all the way through the year. I think that will be crucial in the very large licensing deal as we expect to happen now.

Steven Ralston, Analyst

Just one last question on the cost cutting. I mentioned that at the last conference call. It was obvious in the fourth quarter that some costs had been declining. I’m just looking at the financial statements now. And it looks like at least 25% of the $10 million goal has been achieved. But there’s always a lag in cost cutting. I’m just wondering when these things have been implemented, especially the executives taking some of their fees in stock. When was that implemented? And do you have a sort of a guideline of how much you’ve accomplished in the cost cutting so far?

Cameron Reynolds, President and Group Chief Executive Officer

Terig, would you want to take that?

Terig Hughes, Group Chief Financial Officer

Yes, sure. So most of the $10 million will come in the balance of the year or rather the run rate will reduce over the balance of the year. Our intention is to get to the point where going into next year we’ll have $10 million less in expenditure from an OpEx point of view. But obviously, that’s going to take time to come, and we have already made a good start, but it’s from the second quarter rather than the first quarter. Savings that you might see in the first quarter were actually from a previously announced round of savings that we made. If you recall, we mentioned that back in Q3. You should see a continuation of that reduction through the balance of the year. The main savings will start this quarter and then will continue until we’re on a run rate which is about $10 million less by the end of the year. Does that answer your question, Steven?

Cameron Reynolds, President and Group Chief Executive Officer

And to be clear, Steven, the run rate to the changes we announced last time was $2 million or just a little around that. This is an addition, there’s a $10 million addition to that. So it’s not $10 in total, but this is a new $10 million we’re doing now. The reductions seen in our salaries to switching to equity will be starting this month and next month and throughout the end of the year or for at least six months. So they’re starting right now, and then it’ll be a strong process through the end of the year to get to where we need to get to. But this $10 million is in addition to the ones we announced before, just to be clear.

Steven Ralston, Analyst

Yes. Thank you. That’s more information than I expected.

Cameron Reynolds, President and Group Chief Executive Officer

Excellent. Thanks for your time.

Operator, Operator

Our next question comes from Richard Deutsch of Sutter Securities.

Richard Deutsch, Analyst

Yes. Thank you for taking my call and for doing such important work in what would be two very exciting companies if they were separated. Just a question, you’re placing your cancer tests in the veterinary offices and in the laboratory. Are there any other venues such as pet grooming franchises where these tests could be located and produce extra revenue for those businesses?

Cameron Reynolds, President and Group Chief Executive Officer

Gael, do you want to touch that?

Gael Forterre, Chief Commercial Officer

Yes. So for now, we are really focusing on the large vet reference labs and point of care, but we have no plan at this stage to expand beyond. As we scale, that’s something we might look into, but not for now.

Cameron Reynolds, President and Group Chief Executive Officer

I think that’s exactly right. But I’d just like to say what the fantastic thing with our platform is it can be done on a small machine like the Antech machine. It can be done in a lab. It can be done on a lateral flow. It can be done on a very large auto-analyzer. So that’s the fantastic thing in the variability of our platform, which gives us tremendous strength. Each has a very important use at different areas and different locations. We have developed it now on the microtiter plates on the I-10, which is now part of PerkinElmer, also, the Antech machine, and we’re also working on lateral flow. All the large auto-analyzers the big companies have when we’re doing the licensing deals, for example, in sepsis and coagulation, they should be able to adapt to all their machines as well. So it’s amazingly adaptable going forward.

Operator, Operator

Ladies and gentlemen, we have reached the end of our question-and-answer session. I will now hand over to Cameron Reynolds for closing remarks.

Cameron Reynolds, President and Group Chief Executive Officer

Thank you everyone for joining us today. It’s obviously a very critical time for us now that we have a very wide range of technologies and products we’re commercializing. It should be a very interesting back end of the year, particularly with the ongoing data rooms and licensing discussions in both the human cancer and sepsis space, and of course, with the deals we have just signed in the veterinary space. So it should be a very, very important and exciting end of the year. Thank you again for your interest in Volition.

Operator, Operator

Thank you. Ladies and gentlemen, that concludes today’s event. Thank you for attending and you may now disconnect your line.

Louise Batchelor, Group Chief Marketing and Communications Officer

Thanks very much, Judith. Thank you.